OM-85BV for prevention of respiratory tract infections
- Conditions
- Acute respiratory infectionsInfantchildM01.060.703M01.060.406
- Registration Number
- RBR-9z764g
- Lead Sponsor
- Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Data analysis completed
- Sex
- Not specified
- Target Recruitment
- Not specified
Both female and male children 1 to 5 years old; daycare or preschool attendance; written informed consent signed and dated by a parent or legal guardian in accordance with the ethical standards of the local ethics research committee.
Children diagnosed with asthma, cystic fibrosis, major systemic condition, immune disorders, suspected malabsorption, known allergy to bacterial extracts, major surgery within 3 months of study entry, recent immunosuppressive, immunostimulant or corticosteroid therapy or any other chronic disease that might affect the results; premature babies (less 36 weeks gestation); children participating in other research studies during this project; children who have received OM-85 or any other immunostimulatory or immunosuppressive agents including cyclosporine.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in the number of respiratory infections (rhinopharyngitis, otitis, sinusitis and pneumonia) in the 06-month period, verified by telephone survey, based on a 50% reduction in the mean number of recurrent respiratory infections in the treated group compared to the placebo group.;There was no significant difference in the number of respiratory infections in both groups.The mean in the group receiving OM-85 BV in the first 3 months was 0.92 ± 0.87 and in the placebo group was 0.74 ± 1.02 (p = 0.26) and at 6 months it was 1.62 ± 1.47 and 1.03 ± 1.34, respectively (p = 0.94).
- Secondary Outcome Measures
Name Time Method